MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM; ULTRASONIC SURGICAL DEVICE

Model Number T3905

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's output issue was not confirmed.The evaluation found the gripping surface was worn out and partially peeled off and scratches on the probe tip were found.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.E1/establishment name: (b)(6) hospital added here due to character limitation in respective field.

Event Description

The customer reported to olympus, the sonosurg curved scissors experienced an output problem, and the tissue pad was worn out.The issue was found during an unspecified therapeutic procedure.The procedure was completed with a similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to g2 (inadvertently selected healthcare professional).Three good faith effort (gfe) attempts were made to receive additional information from the customer.A response was no received.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, based on the results of the actual investigation, it is possible that the event pointed out may have occurred due to some load applied to the probe during the procedure, but it could not be identified.It is likely that the scratches on the probe were caused by the following factors.1) ultrasonic output was performed in contact with a hard substance such as a clip or forceps.2) when removing dirt adhering to the probe, it was removed with a sharp object such as a scalpel.The event can be detected/prevented by following the instructions for use which state: "do not activate output when closing the instrument and nothing is grasped between the grasping section and the probe, or when it is not possible to confirm that the tissue being grasped has been completely resected.Otherwise, abnormal heat generated by friction between the grasping section and the probe may damage the grasping section or cause it to detach or premature wear in the grasping surface.Do not close the gripping part and output it without grasping anything between the gripping part and the probe tip, or when it is not possible to confirm whether the grasping tissue has been separated.Abnormal heat generation caused by friction between the gripping part and the probe tip may lead to breakage, deformation, falling off, or severe wear of the grasping surface.Do not activate ultrasonic output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such a metal clips or other instruments (e.G., metal clips, uterine manipulators, or other instruments).Do not apply only the probe to the tissue with strong force or do not twist or pull the probe up while grasping the tissue.Otherwise, the probe may become too hot and break before the generator gives a warning lamp/sound.This product is intended for soft tissues.Do not use the probe tip to hold hard tissues such as bone or calcified tissue, or metal clips or other surgical equipment (e.G., uterine manipulators).The probe may become too hot and break off before the ultrasonic output, warning indicator light is lit, or a warning sound is heard.When body fluids or tissue adhere to the grasping section, the probe and/or the surface of the insertion section during a surgical operation, immediately remove it by wiping with a sterilized piece of gauze or by immersing them in saline solution.If saline solution or blood gets between the probe and insertion section, wipe it away with a sterilized dry piece of gauze.Adhering material may solidify and makes it harder to operate the grasping section or cause instrument damage.During surgery, remove fluids and tissues adhering to the grasping area, probe, or the surface of the insertion site immediately on the spot by immersing them in saline or wiping them off with sterile gauze.If the product is left unattended, the opening and closing of the gripping part will become heavy, the load on the tip of the grasping part will increase, and the load on the probe will increase, causing oscillation failure or failure".Olympus will continue to monitor field performance for this device.

• Brand Name: SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18254189
• MDR Text Key: 329551248
• Report Number: 9614641-2023-01834
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170235665
• UDI-Public: 04953170235665
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T3905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1